Presentation on theme: "Management of Intellectual Property (IP) in CSIR Laboratories"— Presentation transcript:
1 Management of Intellectual Property (IP) in CSIR Laboratories CSIR-WIPO Workshop on Negotiating Technology Licensing AgreementsIndia Habitat Centre, New Delhi, 4-8 July 2005RK Gupta, HeadIntellectual Property Management DivisionCouncil of Scientific & Industrial ResearchIndia
2 CSIR Mission“To provide scientific industrial R&D that maximizes the economic, environmental & societal benefits for the people of India”Serve the Nation
3 IP IN CSIR: CHRONOLOGY1942: Formation of CSIR:Applied & Industrial R&D-Central Patent Cell-Indian Patents-Individual Initiative-Sporadic Licensing of Technology1970: New Patents Act: Flip To Pharma, Food & Chemical Sectors- Patent Unit- Greater Awareness Creation – Laboratory Initiative- No. 1 Position in India-Licensing of Technology including Patents-Sporadic Foreign Filing1995: India joins WTO1998: India joins Paris Convention/PCT1999: Patent amendment to provide EMR retrospectively from 1/1/95
4 …. Contd 2003: 2nd amendment in Patents Act TK not patentable Term of Patent – 20 yearsDeferred Examination18 months publicationProcess patents for biotech inventionsPatent Tribunal Set up at ChennaiEMR grantedPatents Amendment Act 2005 effective from
5 …….. Contd 1999 – 2004: Plant Varieties and Farmers’ Rights Act Passed Designs, TM /Copyright Acts updated and at par with developed worldGI Registry Set up at Chennai200, 000 designations for India under PCTModernization of Indian Patent Office and its branchesBoost to patenting of drugs, pharmaceuticals, botanicals and bio-tech inventions in CSIR
6 IP Management DG, CSIR LAB DIRECTOR IPMD IPM CELL Staff 28 (Scientists – 13,Technical Support:7, Others:8)PolicyPlanningAll Techno-legal matters(Capturing. drafting, Filing,Prosecution, Litigation)Assisting labs in ValorizationAwarenessIPM CELL1 Scientist and other staffCapturePatent SearchEvaluation+AssessmentGap FillingInternal preliminary DraftingInfringement MonitoringValorization
7 Acquisition & Protection IP Cell In each LabDisclosures and recordalsPublications Scrutinized For IPScrutiny for patentingEarly Spotting of IP and its CaptureAssessment & Filling up of GapsPatent Search and Preliminary DraftingInputs for examination and maintenance
8 ……….. ContdIPMDAwareness, training, capture, disclosure and patentability Assessment, drafting, filing, and prosecution of Indian and Foreign Patents, litigation.Foreign ProtectionWhere to protect, Route – Attorneys, Maintenance, Potential, Expenses, Duration
9 Patent Filing in Different Countries Potential Commercial OpportunitiesProduct/Process Life TimeAlternative Protective MechanismsCost of PatentingDefensive/Deterrent Position with respect to CompetitorsFeasibility of Policing and EnforcementPotential for Trading the PatentPublicity/Advertisement gainsForce Competitors to invest in getting “around the patent”
10 Monitoring Structure GOVERNMENT – Overall CSIR Targets DG, CSIR – Labwise and CSIR TargetsIPMD - Labwise and CSIR TargetsIPMD - Director/IPMC/Division/Unit/Engg./SCDIRECTOR – Division/Unit TargetsIPMC - Division/unit Targets/Engg./SC
11 Stimulating Innovation IndividualsCareer AdvancementCertification From CEOMonetary Incentives: Sharing Of Monies RealizedLabRequirement for performance appraisalCompetitive pressureCSIRTarget setting publiclyNational expectation
12 Meeting post WTO challenges To meet the challenges under new IP regime, CSIR announced its IP Policy in 1996 which envisaged:“The maximization of the benefits to CSIR from its intellectual property by stimulating higher levels of innovation through a judicious system of rewards, ensuring timely and effective legal protection for its IP and leveraging and forging strategies alliances for enhancing the value of its IP.”CSIR sets up its own targets of developing a portfolio of 1000 Indian and 500 Foreign patents by 2001.
13 ELEMENTS OF IP MANAGEMENT POLICY Awareness, Motivation & PromotionIP Management SkillsMatrices For PerformanceAcquisition & ProtectionAudit & ValuationValorizationIncentives & RewardsMonitoring & Review
17 Top PCT applicants in 2002 Rank Applicant Country No 1 Council of Scientific & Industrial ResearchIndia1862Samsung Electronic Co.Rep of Korea1843Biowindow Gene Development IncChina1364LG electronics Inc1255Huawaei Technologies Co.846Ranbaxy Laboratories Ltd.567LG Chem Ltd.478SAE Magnetics (H.K.) Ltd.319The National University of SingaporeSingapore2810Philips Electronics Singapore PTE Ltd.24
18 Top PCT applicants in 2003 *CSIR filed 213 PCT applications in 2003 PositionOrganisation1LG Electronics (Republic of Korea)2Samsung Electronics Co. Ltd. (Republic of Korea)3Council of Scientific and Industrial Research (CSIR) (India)*CSIR filed 213 PCT applications in 2003
27 Valorization of IP Clustering Filling Gaps Bubble Patents Portfolio formationValuationForging Strategic AllianceLicensing/Bartering/SaleCSIRLabAgentsPublic-Private PartnershipRegulating AccessStrengthening Linkages with IndustryAdopting new models for valorization of IPEnforcement - Action against Infringement
28 Reaching the Current Stage How ?Training of IPMD ScientistsTraining of CSIR IP Coordinators and scientists by leading US and European patent attorney firms, and, consultants; WIPO, Patent Office Experts from USPTO, EPO and Japan.Experts from Multinationals (Pfizer)Training of scientists in patent search, initial assessment of disclosure, preparation of provisional patents and internal evaluationTraining of scientists in patent examinationTraining of scientists in valorization, licensing, arbitration and litigation.
29 Reaching the Current Stage Model for other publicly funded organisationsModel for industrySupport System for Universities through formal and informal channelsRole in impacting national IP PoliciesRole in formulating Universities’ IP Policies
31 IP Licensing: Approvals for Licensing of IP Director/Management CouncilDG, CSIR
32 Licensing of IP Direct Licensing by the Laboratory Licensing of IP through TTAs/Business consultants/NRDC
33 Licensing IP: Pricing of IP Cost of developmentCost of securing the IPCost of maintaining the IPIntellectual FeeService Tax
34 Sharing of Premia/Royalty received from Licensing of IP/Knowledgebase CSIR 60%INVESTIGATORS 40%
35 Distribution of Monies Realised Innovators & Principal ContributorsS&T and other staff who contribute direct inputs to the specific development/activityRemaining Staff of the laboratoryCSIR Welfare fund (maintained at HQ)
37 Streptokinase -Success Stories in Licensing - I Increasing No. of people suffering from heart diseases worldwide and specially in IndiaCause of death – development of a blood clot causing vascular blockagePrevention by timely intravenous administration of a thrombolytic agentProblem-Non availability of affordable thrombolytic agent within six hours of the onset of heart attackDrugs commonly used are tissue plasminogen activator, urokinase and streptokinaseMarket demand for thrombolytics Rs. 1 bnStreptokinase - 80% of the demandGrowth in demand - 20% annualy
38 Success Stories in Licensing - I IMTECH developed first indigenous clot buster drug ‘STPase’ and it was launched in market in 2000 through Cadila PharmaIMPACT – crash down of the price from Rs. 3,500 to Rs. 2,000 per doseMilestone payments based on the demonstration of the technology i.e 98% purity at 20/100 L scalesRoyalties started from the date of commercial production
39 Success Stories in Licensing - I Further R&D work by the lab for the production of recombinant natural type SK at a level nearly 10 times of natural SKThe product is licensed and regulatory testing for rDNA based theraupatics has been completed and this drug is likely to be available at most affordable cost.Licensing model - milestone payments/royaltiesLicensing possible because of IP protection in India, USA & Europe
40 Success Stories in Licensing - II NCL-GE Alliance – originated in 1993.GE supported the R&D at NCLAlliance operated for over 9 years successfully and emerged as a paradigm in “relationship” management in R&D.Cash flow to NCL from GE of around USD 8.5 m over the period toExposure to and training of NCL scientists to world class R&D management practices.
41 Success Stories in Licensing - II Building up of world class facilities and resources in NCLAttracting and hiring of talented young scientistsNew contract research opportunities with multinational companiesDiffusion of ideas and generic methods developed to Indian industriesHalf a dozen patents assigned to GECSIR owns several patents based on generic ideas developed while interacting with GE having relevance to systems other than polycarbonates
42 Success Stories in Licensing - II Ushering into NCL the understanding, importance and culture of IPR.Spin off: THPE [1,1’,1”-Tris(4’-hydroxyphenyl) ethane] is a branching agent used in the synthesis of high grade polycarbonates with properties of high transparency, good mechanical and high parison strength.Hoechst Celanese USA, was the only supplier of THPE to the global market. In 1994, NCL initiated a program, funded by GE aimed at developing a proprietary process for THPE.
43 Success Stories in Licensing - II Patents were filed in India and abroadExcel has exported THPE valued at around Rs. 30 Crore over the three year periodNCL has received US $ 50,000 as license fee and royalty payment of around US $ 1,00,000.NCL’s endeavour has led to an Indian firm challenging and breaking global monopoly of a single supplier.
44 Success Stories in Licensing - III United States Patent 6,893,479 (CSMCRI)Integrated method for production of carrageenan and liquid fertilizer from fresh seaweeds “An integrated method is developed to utilize to a maximum extent the fresh biomass of seaweeds such as Kappaphycus alvarezii that can be crushed to release sap and where the sap is useful as a potent liquid fertilizer after suitable treatment with additives and dilution while the residue is a superior raw material for extraction of κ-carrageenan, thereby enhancing the value of the seaweed. Other advantages of the invention include a reduced drying time and drying area to obtain the raw material for κ-carrageenan production in dry and storable form, a reduced cost of transporting and storing this raw material because of its lesser bulk, easier handling due to its free flowing granular nature, and its direct use for gel preparation in certain applications”
45 Success Stories in Licensing - III CSIR licenses Sea Weed Technology to PepsicoA plant growth harmone and regulator is derived from fresh Sea Weed grown along the shoreline.Liquid Sea Weed Fertilizer increases yields from same seed by 10% for wheat, 30% for peddy, 20-30% for fruits and vegetables to 35% for corn and chana, BT cotton 20%, Banana for 19%.Patent applications fined in India, US and other countries
46 Success Stories in Licensing - III Trials in Punjab, Andhra Pradesh and Gujarat.Realizing the employment generation potential of aqua-agriculture, DBT, ICAR other government deptts. are now pushing sea weed cultivation as a promising money spinner for rural populationSocial Impact: Hundreds of women along the shoreline can look forward to earning more than Rs. 12,000 a month as pepsi suppliers.
47 Success Stories in Licensing - IV Mint oil is used mainly for producing menthol and the by-product dementholised oil (DMO) which finds uses in pharmaceutical and cosmetic industry.Menthol has a cooling, refreshing aroma and antiseptic properties.The current world-wide consumption of natural and synthetic l-menthol in the cosmeticeutical and cigarette industries is estimated at about 15,000 and 3,000 metric tons, respectively.
48 Success Stories in Licensing - IV About 15 years ago bulk of l-menthol rich essential oil of M. arvensis for international use came from Brazil and China.Later China and India became the main exporters.In the last few years India has come to occupy 1st position in the trade of M. arvensis essential oil and its products.
49 Success Stories in Licensing - IV Social Impact:Estimated area and production of menthol mint duringYearArea (ha)Production of oil (t)1994450005000199612000090001998133000120002000150000140002002# Employment Generation# Enhancement in rural earning
50 Success Stories in Licensing - IV A new and distinct variety "Himalaya" of Mentha arvensis, (US Patent No. PP10,935) has been developed by CIMAPcharacterized by its higher yield of oil which is rich in menthol; improved regeneration potential; tolerance to rust, alternaria leaf blight, corynespora leaf spot, and powdery mildew; vigorous growth; deep green broad thick leaves; and pinkish white flowers.
51 Success Stories in Licensing - IV CIMAP developed another novel mint plant "Kosi" (US Patent No. PP12,426)Characterized by its high biomass and high oil yield with synchronous branching giving globular shape to the canopy for equal distribution of sunlight to the lower leaves
52 Success Stories in Licensing - IV Another novel high menthol producing plant "Saksham" (US Patent No. PP13,279) developed by CMIAP obtained through metabolic engineering, a unique method of screening of the somaclones in poison agar medium containing toxic level of menthol.Tolerant to high concentration of menthol in cultures and hence possesses property of accumulating more menthol per unit leaf mass
53 Success Stories in Licensing - IV A new and distinct interspecific mint hybrid "Neerkalka" (US Patent No. 12,030) developed by CIMAP through sexual crossing between improved Mother plant Mentha arvensis (cv Kalka) and pollen plant Mentha spicata (cv Neera).The hybrid is propagated vegetatively by suckers or stem cuttings and is stable for commercial cultivation.
54 Success Stories in Licensing - V United States Patent 6,858,141 (NCL)Process for the preparation of ultrafiltration membranes of polyacrylonitrile, using malic acid as an additive“A process for the preparation of ultrafiltration membranes from polyacrylonitrile using malic acid as additives, with said membrane of molecular weight ranging between 80 to 180K, showing high purification and water permeating ability.”# Cost of water purification (Bacteria + Virus free) few paise per litre as compared to Rs. 10 per litre of mineral water# Licensed to the industry recently; Social Impact- Very high
55 Other Success Stories from CSIR Each lab created several such success stories in recent yearsLicensing was possible because of IP protectionValue realization is a long term processSeveral proposals for IP licensing in the pipeline – all because of IP protection nationally and internationally.
56 Doing Business with IP – Challenges Public-Private PartnershipRegulating AccessStrengthening Linkages with IndustryVenture CapitalCompeting at a fast paceWorking towards Technology oriented systems of InnovationAdopting new models for valorization of IPFocusing on Socially relevant technologiesAdopting best practices in IP Licensing